anaesthetic & critical care studies summaries

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Protocol v2.0 06/12/2023
Rotherham Principal Investigator: Professor Anil Hormis
Research team members: Cheryl Graham/Dr Katie Webb

research topic:

Glucocorticoids in adults with ARDS

trial groups:

Intervention: Dexamethasone plus usual care (16.5mg for 5 days, then 8.25mg for 5 days)
Control: Usual care alone (no high dose glucocorticoids)

inclusion criteria:

• > 16 years old, admitted to HDU/ITU
  
• Receiving respiratory support via invasive mechanical ventilation or non-invasive ventilatory support (non-invasive ventilatory support includes mask or helmet) or high flow nasal cannula (HFNC) >30L/min
  
• Within 72 hours of diagnosis of ARDS with moderate to severe hypoxaemia defined as:

1. a known acute clinical insult or new or worsening respiratory dysfunction (Note: this includes new deterioration at any time-point during the ICU stay), and
   
2. opacities on chest imaging not fully explained by effusions, lobar/lung collapse/atelectasis, or nodules, and
   
3. respiratory failure not fully explained by cardiac failure or fluid overload, and assessment of hypoxaemia done with either PaO2/FiO2 ratio <26.7 kPa from arterial blood gases, or SpO2/FiO2 <235 with SaO2<97%

We will include patients requiring other immunosuppressive drugs, provided there exists clinician equipoise for randomising such a patient.

exclusion criteria:

• ARDS due to microbiologically confirmed SARS-Co-V2 infection (COVID-19 ARDS)
  
• High dose glucocorticoids are required for a separate proven clinical indication at the time of randomisation as withholding treatments that have been deemed clinically effective, would be unethical.
  
• Infections that are not being effectively treated as determined by the treating medical team.

Note there are more exclusions not listed in this summary
 

consent:

Formal consent is required for GuARDS trial enrolment/randomisation. If you think your patient is in any way eligible please contact the research team who will review the full inclusion/exclusion criteria and approach for consent.